MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number	FRED4528-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The stent was implanted in the patient and not returned to the manufacturer for analysis.Intraprocedure images were provided by the physician.The review of the provided media identified the fred stent, however no post-procedure images of a thrombus were provided.Without post-procedure images or the physical evaluation of the device, further investigation cannot be performed.The instructions for use identifies thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that the fred was successfully implanted to treat an aneurysm in the left internal carotid artery.Two weeks post-procedure, thrombus was identified within the stent and a thrombectomy was attempted, without success.There was no reported device malfunction.It was reported that the patient was not compliant with the post-procedure dual anti-platelet medication.The patient is being managed medically.There was no reported sequela.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11319057
• Report Number: 2032493-2021-00040
• Device Sequence Number: 4088690
• Product Code: OUT
• UDI-Device Identifier: 00842429106792
• UDI-Public: (01)00842429106792(11)200505(17)230430(10)200505563
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: FRED4528-PMA
• Device Lot Number: 200505563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention